The Merit WRAPSODY Central Feasibility Study

Not Applicable

Withdrawn

• Conditions: Venous Occlusion; Venous Stenosis
• Interventions: Device: Merit WRAPSODY Endovascular Stent Graft

• Registration Number: NCT04541576
• Lead Sponsor: Merit Medical Systems, Inc.

Brief Summary

The purpose of the study is to demonstrate the safety and efficacy of the Merit WRAPSODY Endovascular Stent Graft for treatment of stenosis or occlusion within the dialysis access outflow circuit in the thoracic central veins

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-09-01
• Study First Submitted QC: 2020-09-01
• Study First Posted: 2020-09-09
• Study Start: 2021-03
• Status Verified: 2021-04
• Last Update Submitted: 2021-04-16
• Last Update Posted: 2021-04-20
• Primary Completion: 2022-07
• Study Completion: 2024-02

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Subject provides written informed consent
• Subject is male or female, with an age ≥ 18 years at date of enrollment.
• Subject is willing to undergo all follow-up assessments.
• Subject has a life expectancy ≥ 12 months.
• Subject is undergoing chronic hemodialysis.
• Subject has either a mature AVF or AVG in the arm.
• Target lesion(s) involves a non-stented restenotic lesion.
• Target lesion has ≥50% stenosis.
• Target lesion(s) reference vessel diameter is between 5.0 mm and 14.0 mm

Exclusion Criteria

• Subject is unable or is unwilling to comply with the procedural requirements of the study protocol.
• Subject has a comorbidity that in the investigator's opinion would limit life expectancy to less than 12 months.
• Subject has a known or suspected infection of the hemodialysis access site, systemic infection and/or septicemia.
• Subject has a stroke diagnosis within 3 months prior to enrollment.
• Subject has a history of unstable angina or myocardial infarction within 60 days prior to enrollment.
• Subject is pregnant, breastfeeding, or intending to become pregnant within the next year.
• Target lesion is located within a stent / stent graft.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
WRAPSODY Stent Graft	Merit WRAPSODY Endovascular Stent Graft	All subjects will receive treatment via WRAPSODY Stent Graft Placement.

Primary Outcome Measures

Name	Time	Method
Proportion of subjects without any localized or systemic safety events (Primary Safety Endpoint	30 days	Proportion of subjects without any localized or systemic safety events through 30 days post-index procedure that affect the access or venous outflow circuit and resulted in intervention, hospitalization, or death.
Proportion of subjects with Target Lesion Primary Patency (TLPP) (Primary Effectiveness Endpoint)	6 months	Proportion of subjects with Target Lesion Primary Patency (TLPP) at 6 Months. TLPP is defined as freedom from clinically-driven target lesion revascularization (CD-TLR) or target lesion thrombosis measured through 6 months post-procedure, which is the time interval of uninterrupted patency after study procedure to the next intervention performed on the target lesion or uncorrectable target lesion occlusion.

Secondary Outcome Measures

Name	Time	Method
Proportion of subjects with Access Circuit Primary Patency (ACPP)	6, 12 and 24 months
Rates of procedure- and device-related adverse events involving the access circuit	Index procedure, 30 days, and months 6, 12 and 24.
Proportion of subjects with Assisted Target Lesion Primary Patency (aTLPP)	6, 12 and 24 months
Proportion of subjects with Target Lesion Primary Patency	12 and 24 months
Proportion of subjects with Post-Procedure Secondary Patency	6, 12 and 24 months